N/A
N=396
A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
Xerostomia
Bottom Line
View on ClinicalTrials.gov: NCT03494985 ↗Enrolled (actual)
396
Serious AEs
0.8%
Results posted
Jul 2018
Primary outcome: Primary: Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth) — 2.7; 2.9; 2.6; 2.0 Score on scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Oralbalance Moisturizing Gel (Device); Biotene Original Oral Rinse (Device); Biotene Moisturizing Mouth Spray (Device); Water (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth) |
2.7; 2.9; 2.6; 2.0 | <0.0001 sig |
| SECONDARY Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29 |
3.0; 3.2; 3.1; 2.3; 2.9; 3.2 | — |
| SECONDARY Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1 |
2.8; 2.8; 2.7; 2.2; 2.8; 2.7 | — |
| SECONDARY Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I) |
3.1; 3.0; 2.9; 2.5; 2.9; 2.8 | — |
| SECONDARY Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8 |
2.8; 3.0; 2.9; 2.1; 2.9; 3.0 | — |
| SECONDARY Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II) |
2.5; 2.7; 2.6; 2.2; 2.7; 3.0 | — |
| SECONDARY Area Under Curve (AUC) up to 4 Hours After Treatment- Response of All Question of the Modified Product Performance and Attributes Questionnaire I (PPAQ I) |
2.6; 2.5; 2.5; 1.9; 2.7; 2.9 | — |
Summary
This study assessed the efficacy of three dry mouth products (including an experimental Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth compared to water, in dry mouth population over a period of 28 days.
Eligibility Criteria
Inclusion Criteria
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination., b) Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. Subjects with stable and controlled medical conditions with no overt medical conditions which would contraindicate participation (in the opinion of the Investigator or medically qualified designee) which would interfere with the conduct of the study.
- Self reported feeling of a dry mouth according to the modified DMI questions. Subject must answer at least 3 out of 5 questions with 'agree a little', 'agree' or 'strongly agree'.
Exclusion Criteria
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last 1 year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family.
- Subject works in one of the following: Advertising, Journalism, Public Relations, Manufacturing, retail or distribution of medicines, medical devices or healthcare products, Market Research or Marketing.
- Use of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth.
- At the discretion of the examiner, subjects currently under the care of a dental/medical professional specifically for the treatment of dry mouth.
- Evidence of gross intra-oral neglect or need for extensive dental therapy.
- Denture wearer (partial or complete dentures).
- Subject with dental implants.
- Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration).
- Subject is currently undergoing radiotherapy and/or chemotherapy treatment.
- Any condition the investigator identifies that can confound the subject's ability to properly participate in the study e.g. Alzheimer's Disease.
Data sourced from ClinicalTrials.gov (NCT03494985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.